A new Clinical Laboratory Improvement Amendments option for risk based quality-control (QC) plans became effective in January, 2016. Called an Individualized QC Plan, this option requires the laboratory to perform a risk assessment, develop a QC plan, and implement a QC program to monitor ongoing performance of the QC plan. Difficulties in performing a risk assessment may limit validity of an Individualized QC Plan. A better alternative is to develop a Total QC Plan including a right sized statistical QC procedure to detect medically important errors. West-gard Sigma Rules provides a simple way to select the right control rules and the right number of control measurements.
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